Lyme Serum and CSF Analysis
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
|Test ID||Reporting Name||Available Separately||Always Performed|
|FLAS||Lyme Antibody Analysis, Serum||No||Yes|
|FLAC||Lyme Antibody Analysis, CSF||No||Yes|
Antibody Capture Enzyme Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Lyme Ab Analysis Serum and CSF
Lyme Capture FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Requires Serum and CSF
Draw blood in a red-top tube(s). Spin down and submit 2 mL refrigerate serum.
Collect 1 mL CSF in a sterile plastic vial and submit refrigerate.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Serum: 0.2 mL; CSF: 0.5 mL
Specimens other than
Serum and CSF
Anticoagulants other than
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|CSF||Refrigerated (preferred)||5 days|
|Serum Red||Refrigerated (preferred)||5 days|
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
A final report will be attached in MayoAccess.
Test Performed by: IMUGEN Reference Diagnostic Division
315 Norwood Park South
Norwood, MA 02062
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
1 - 2 days
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
3 - 8 days
Performing Laboratory Location The location of the laboratory that performs the test
IMUGEN Reference Diatnostics Division
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
IMUGEN has developed and verified the performance characteristics of this test under the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). It has not been cleared or approved by the US Food and Drug Administrations (FDA). The FDA has determined that such clearance or approval is not necessary.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
Lyme Antibody Analysis, Serum
86317 - IgA
86317 - IgG
86317 - IgM
86317 x 2 - Western blot
Lyme Antibody Analysis, CSF
86317 - IgA
86317 - IgG
86317 - IgM
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|Z2602||Lyme Antibody Analysis, Serum||In Process|
|Z2603||Lyme Antibody Analysis, CSF||In Process|